Insulin Syringe— 510(k) K223453

Substantially Equivalent

Promisemed Hangzhou Meditech Co., Ltd.

FDA 510(k) clearance K223453 for Insulin Syringe, Substantially Equivalent on 2023-03-02. Applicant: Promisemed Hangzhou Meditech Co., Ltd..

Clearance details

Applicant: Promisemed Hangzhou Meditech Co., Ltd.
Product code: Code FMF
Advisory panel: General Hospital
Date received: 2022-11-16
Decision date: 2023-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou City, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code FMF

product code FMF

Death: 15
Injury: 2,263
Malfunction: 29,722
Other: 17
Total: 32,017

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.